Hepatitis B Vaccines made from Human Plasma

Immunity plays a crucial role in the human body fighting against various diseases and infections attacking it. If a human immune system is prepared to withstand a disease it is said to be immune to the following disease. Immunity is sometimes gained naturally by suffering and surviving the infection and conquering it. This is called naturally acquired immunity. With naturally acquired immunity, one suffers the symptoms of the disease and also faces the complications, which can be sometimes dangerous. Apart from naturally acquired immunity, artificially acquired immunity can also be attained by the human body through vaccines which is the easiest and the less risky way to get immune against any disease.

Vaccine made from Biological Products prevents diseases from occurring at the first place, rather than attempting to cure it after getting it. In fact, it is cheaper to prevent a disease than to treat it as in the course time you can face many complications and also can spread it to people around you. Vaccines protect the human body against infectious diseases caused by microbes and viruses by generating antibodies in the body to fight against the infectious conditions.

Vaccines protect the human body against various diseases like chickenpox, hepatitis A, hepatitis B, and Haemophilus influenzae type b (Hib) etc.

Vaccines for hepatitis B:

Hepatitis B is a serious disease that is killing about 4k to 5k of Americans every year and 1 million people around the world. Hepatitis B is caused by infection with the hepatitis B virus, termed as HBV. Persons with HBV infection have this virus circulating in their blood, much like hepatitis C virus (HCV) and human immunodeficiency virus (HIV). Persons who become infected with HBV either recover from their infection in several months or they may remain chronically infected for most of their lifetime. Also, majority of people in U.S.A go under liver transplant each year, out of which 16% were done due to infections caused by hepatitis B.

Although most people do not show symptoms of HBV infection, however blood tests can accurately identify the conditions of the life taking disease. Adults who are chronically infected by HBV have a 15% chance of dying from liver disease whereas young children or infants have a 25% chance to die due to liver cancer. So, prevention of such infection is very crucial as if once a person is infected, there are only few treatment options available that are much expensive too.

Apparently, prevention is better than cure. Vaccines prove to be a life saving option for the persons suffering from HBV. There are about 15 different types of Hepatitis B vaccines available today around the world.

The first Hepatitis B vaccine was developed in 1981. It was derived from donated human plasma and was known as PDV (Plasma Derived Vaccine). It is prepared from particles of HBsAg obtained from human plasma, which is purified thus delivers 95% pure Biological Products. These vaccines are subjected to inactivation with formalin and heat and are adjuvant with compounds of Aluminium. Plasma derived vaccine is presently available for large-scale, public-sector purchase with valid medical prescription. It is used widely used today as the best preventive for HBV.

However, it comes with minor side effects associated with it. The vaccine is though suitable for all persons, some cases suffer through mild swelling, tenderness and redness at the place of the injection. Other minor reactions such as malaise or fever occur in less than 2% of individuals. However, more serious reactions are rare has not been detected.

The World Health Organization has stated that plasma derived vaccines (PDV’s) are safe and effective type of vaccines made from Biological Products for all age groups.

Products derived from human plasma

Plasma is a major constituent of human blood that is packed up of large number of proteins in it. These plasma proteins play a major role in transportation of blood and various other vital substances in human body. These proteins are responsible to carry out vital body functions like blood clotting, defending body against attacks by diseases, transportation of various substances in the blood and cleansing the blood by flushing out the toxins. This miracle substance plasma works as a firewall protecting the human body against external agents and keeping it healthy.

However by Donating Plasma one can contribute this substance for helping the other fellow beings. The plasma when taken out from human body can be fractionated, purified, and used to treat diseases caused from defects in these plasma components of other human bodies. Donating Plasma is helping the healthcare industry to develop range of Plasma Products that can be used as a medication in treatment of various chronic diseases.

These plasma derived proteins or Plasma Products are developed by collecting the Donating Plasma samples of thousands of donors. Once collected appropriate processing is done and the product is preserved for future use. However, the processing of plasma is very costly and time taking. Blood plasma once processed can be used in manufacture of various Plasma Products.

The major Plasma Products that are derived from human blood plasma are:

·         Intravenous Immunoglobulin (IVIG)

·         Albumin

·         Clotting Factors

·         Hyper Immunes

Intravenous Immunoglobulin (IVIG):

Intravenous Immunoglobulin (IVIG) contains pooled, polyvalent, IgG extracted from the plasma of over one thousand blood donors. It is a blood product that is administered intravenously to the patients. This Plasma Product is used to treat immune deficiencies, inflammatory and autoimmune diseases, and acute infections in the human body. When IVIG is administered to the patients it effect last up to 2weeks to 3 months in the body.

Albumin:

Serum albumin is the most abundant blood plasma protein constituting about 60% of whole blood plasma protein. It is produced in the liver and is responsible for regulating osmotic pressure of the human blood compartments. The albumins also act as carriers for molecules of low water solubility, hormones, bile salts, calcium and various drugs in the human body. Albumin is often used to replace lost body fluid and to help restore blood concentration levels in various conditions like trauma, burns and surgeries in patients.

Clotting Factors:

Clotting Factors are the unique plasma products that can be derived only form human blood plasma. They are the best known plasma products and the key components of coagulation. These plasma products are administered to patients who are genetically unable to produce all of the components necessary for Blood clotting. The most commonly known need is for Factor VIII, a Blood clotting agent, by hemophiliacs.

Hyper Immunes:

Hyper Immunes are also like Intravenous Immunoglobulin (IVIG) except that it is developed from the Donating Plasma samples of donor with high titers of specific antibody count in them. These Plasma Products administration provides passive immunity to the patient against various agents in the human body. They provide instant results but have serious side effects also associated with their dosage.

Seemingly all these plasma products are proving to be very useful in increasing the immunity of the patients and curing various diseases. By Donating Plasma all individuals can contribute in the development of medicines and vaccines form which these exclusive products to save lives of many patients around the world. Also, the donors are paid on each of their plasma donations so earning while doing a noble deed.

Methods for plasma extraction from human body

The concept of donating your plasma can sound weird to many as it is not very common today like blood donation. But Plasma Donation is similar to blood donations and to say much more safe and healthy for the human body than blood transfusions. In this type of donation only plasma, the liquid part of the blood is taken out and the blood is sent back to the donor body. Though this looks very complex to hear, but this is carried out without causing much pain to the donor. Plasma comes along with many medical benefits associated with it, it is utilized in the development of various medicines and also is used for clinical researches in laboratories.

Plasma is extracted from the human blood at the Plasma Donation Center in different ways to make use of the substance in various ways. The three ways that are majorly used for the extraction process are:

·         Plasma transfusions

·         Fractionation

·         Plasmapheresis

Plasma transfusions: It is the process in which first the entire blood is taken from a human body. The plasma is then separated from the blood by apheresis and is stored at frozen state. This stored substance is called as fresh frozen plasma (FFP). Whenever the plasma is needed it is thawed and given as a transfusion to another person.

Such Plasma transfusions comes very useful in treating patients who are bleeding due to serious accident or undergoing major surgery where clotting factors need replacing as well as red blood cells.

Fractionation: In this process different plasma donation samples are mixed (pooled) and are subjected to different heat and chemical treatments thus separating all the various proteins from the plasma. This is a very complex procedure and can take up to 5 days. The samples that are collected for the pools go through strict tests and checking to trace for all viruses and antibodies. Then the pooled plasma is carefully filtered and cleaned using heat, detergents and solvents to remove all possible viruses that may be present in it. After the fractionation process has been completed, the plasma products are either freeze dried as a powder for reconstitution before use or are stored as a liquid.

Such extractions can be useful in treating patients with the medical condition such as haemophilia.

Plasmapheresis: This is a plasma exchange method in which a cell separator machine is used to separate the plasma from the human blood. In this process a needle is inserted into a donor’s vein on the arm and the blood is extracted and passed through the cell separator. The plasma is separated from the blood in this machine and the left blood is returned back through a needle by the vein in the other arm to the donor’s body. During this process, only a little amount of blood (less than 100ml) will be taken out from the body at a single time as the blood is being removed and returned at the same rate from the body throughout the process. This procedure takes up to 2 hours to extract the required amount of plasma from a single donor.

Plasmapheresis or plasma exchange is often used to treat patients with rare blood conditions and clotting disorder.

However, all these methods are carried out maintaining full hygiene and care of the donor. Also the donor has to pass through certain tests prior to the extraction in order to get approved for Plasma Donation. Once passed through all the tests, all healthy adults can donate their plasma twice a month at any Plasma Donation Center. The donors are also been paid for giving their Plasma Donation.

Blood plasma fractionation process

Plasma contains a large variety of proteins including albumin, immunoglobulin, and clotting proteins such as fibrinogen in it. These proteins present in it have many important therapeutic uses and clinical uses and can work wonders when used in development of various medicines. These substances are also widely used in medical researches to develop therapies and vaccines for chronic diseases like cancer, tumors and AIDS etc.

In order to get the benefit of these live saving substances plasma is extracted from the human blood through a process called blood fractionation. Human Plasma is the yellowish liquid present in the human blood that constitutes 55% of its volume and is responsible for all the major circulation of it throughout the human body. When this extraction is carried out we get a clear solution of plasma in the upper phase, the Buffy coat, which is a thin layer of leukocytes mixed with platelets in the middle and Erythrocytes (Red Blood Cells) at the bottom of the centrifuge tube. After getting these components separately in the tube, plasma can be separated easily and stored for further use.

Now once the Human Plasma is obtained, its various components can be separated for further usage. However it is also very beneficial and can be used in various forms to create medications wholly. The process of separating the various components of Human Blood Plasma is called as Blood plasma fractionation.

The Human Blood Plasma contains thousands of proteins, however, identifying them presents challenge due to the wide range of concentrations present in it. Let us see different components and their concentration in it.

·         Albumin constitutes about 60% of the total protein in plasma and is present at concentrations between 35 and 55 mg/mL. It is the main contributor to osmotic pressure of the blood and it functions as a carrier molecule for molecules with low water solubility such as lipid soluble hormones, enzymes, fatty acids, metal ions, and pharmaceutical compounds. Due to the structural integrity of albumin it remains stable under conditions where most other proteins denature.

·         Fibrinogen is present at concentrations 1.5-4.0 g/L in Human Blood Plasma or about 7 µM. It is the principal protein responsible for clotting in the human body.

·         Immunoglobulins are the substances that fight against infections in human body. Our bodies create antibodies (Immunoglobulin’s) against disease causing agents when infections occur.

Apart from these there are many other proteins and substances present in the human plasma in minute quantities that also can be separated through the process of Blood plasma fractionation.

The first practical large scale method of blood plasma fractionation was developed by Edwin J. Cohn during World War II. This process is also known as cold ethanol fractionation as it involves gradually increasing the concentration of ethanol in the solution at 5^oC and 3^oC. The Cohn Process exploits differences in properties of the various proteins, specifically, the high solubility and low pl of albumin. However, at each stage certain proteins are precipitated out of the solution and removed. The final precipitate is purified albumin.

Several variations to this process also exist, including an adapted method by Nitschmann and Kistler that uses fewer steps, and replaces centrifugation and bulk freezing with filtration and diafiltration. However, the ultimate goal of processing is to get a purified component that can be used for making injection or transfusions. In addition to the clinical uses of a variety of its proteins, it has many analytical uses too. Blood plasma fractionation obtains it in purified state that can be utilized for many purposes and have many beneficial factors in it.